Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K013297 |
Device Name |
AIRCAST, MODEL #3011 |
Applicant |
MILLENIUM REPROCESSING SERVICES, INC. |
8850 WOODSIDE DR. |
CLARENCE,
NY
14031
|
|
Applicant Contact |
GARY J SFEIR |
Correspondent |
MILLENIUM REPROCESSING SERVICES, INC. |
8850 WOODSIDE DR. |
CLARENCE,
NY
14031
|
|
Correspondent Contact |
GARY J SFEIR |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 10/03/2001 |
Decision Date | 06/14/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|